About the Client- Top 10 Pharma company in India having Global business in Formulations API and Biologics.
About the Role
We are seeking a senior engineering leader to oversee engineering operations for OSD and sterile formulations manufacturing site. You will lead teams manage infrastructure and drive strategic projects that support the delivery of high-quality sterile products.
Key Responsibilities
- Engineering Leadership
- Lead engineering operations for OSD and sterile formulation facilities (site Engineering Head)
- Ensure reliable performance of utilities HVAC cleanrooms water systems (PW/WFI) and process equipment of Oral solid and injectables.
- Oversee preventive predictive and corrective maintenance programs.
- Compliance & Quality
- Ensure adherence to USFDA EMA MHRA and other regulatory requirements.
- Maintain audit readiness and support inspections with complete documentation.
- Drive data integrity and compliance across engineering systems.
- Collaborate with global teams for standardization and best practices.
- Ensure energy efficiency sustainability and cost optimization in engineering operations.
- Team & Vendor Management
- Lead and mentor engineering teams fostering a culture of safety accountability and innovation.
- Manage vendor relationships for AMC spare parts and technical services.
- Drive training programs for engineering staff on sterile manufacturing requirements.
- Strategic Contribution
- Align engineering strategies with business goals and production targets.
- Provide inputs for long-term capacity planning and risk management.
- Champion digitalization automation and lean practices in engineering.
Qualifications
- B.E./ in Mechanical Electrical Instrumentation or Chemical Engineering.
- 15–20 years of experience in engineering leadership within OSD (Must) and sterile formulations manufacturing.
- Strong expertise in sterile utilities cleanroom operations and aseptic equipment.
- Proven track record in handling audits regulatory inspections and large-scale projects.
- Experience in site engineering management preferred for site engg head role.
- Skills & Competencies
- Strategic leadership and decision-making.
- Deep technical knowledge of sterile manufacturing engineering systems.
- Strong compliance orientation and documentation accuracy.
- Excellent stakeholder management and communication skills.
- Ability to drive innovation and continuous improvement.
About the Client- Top 10 Pharma company in India having Global business in Formulations API and Biologics.About the RoleWe are seeking a senior engineering leader to oversee engineering operations for OSD and sterile formulations manufacturing site. You will lead teams manage infrastructure and driv...
About the Client- Top 10 Pharma company in India having Global business in Formulations API and Biologics.
About the Role
We are seeking a senior engineering leader to oversee engineering operations for OSD and sterile formulations manufacturing site. You will lead teams manage infrastructure and drive strategic projects that support the delivery of high-quality sterile products.
Key Responsibilities
- Engineering Leadership
- Lead engineering operations for OSD and sterile formulation facilities (site Engineering Head)
- Ensure reliable performance of utilities HVAC cleanrooms water systems (PW/WFI) and process equipment of Oral solid and injectables.
- Oversee preventive predictive and corrective maintenance programs.
- Compliance & Quality
- Ensure adherence to USFDA EMA MHRA and other regulatory requirements.
- Maintain audit readiness and support inspections with complete documentation.
- Drive data integrity and compliance across engineering systems.
- Collaborate with global teams for standardization and best practices.
- Ensure energy efficiency sustainability and cost optimization in engineering operations.
- Team & Vendor Management
- Lead and mentor engineering teams fostering a culture of safety accountability and innovation.
- Manage vendor relationships for AMC spare parts and technical services.
- Drive training programs for engineering staff on sterile manufacturing requirements.
- Strategic Contribution
- Align engineering strategies with business goals and production targets.
- Provide inputs for long-term capacity planning and risk management.
- Champion digitalization automation and lean practices in engineering.
Qualifications
- B.E./ in Mechanical Electrical Instrumentation or Chemical Engineering.
- 15–20 years of experience in engineering leadership within OSD (Must) and sterile formulations manufacturing.
- Strong expertise in sterile utilities cleanroom operations and aseptic equipment.
- Proven track record in handling audits regulatory inspections and large-scale projects.
- Experience in site engineering management preferred for site engg head role.
- Skills & Competencies
- Strategic leadership and decision-making.
- Deep technical knowledge of sterile manufacturing engineering systems.
- Strong compliance orientation and documentation accuracy.
- Excellent stakeholder management and communication skills.
- Ability to drive innovation and continuous improvement.
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